Quality Assurance Engineer - Medical Devices
Location : Monroe NY US 10950
Job Type : Direct
Reference Code : 19259-BZ1
Compensation : 70000.00 - 90000.00 USD/YEAR
Hours : Full Time
Required Years of Experience : 5
Required Education : BS Engineering or Science
Travel : No
Relocation : No
Job Industry : Medical Devices
Job Description :
- Permanent position for a Quality Assurance Engineering Specialist responsible for leading and reviewing design control activities such as risk management, validation, design review, and ensuring that Design History Files are complete, accurate, and compliant with procedures.
- Support internal and external manufacturing operations and serves as the primary Quality contact for new product pipeline.
- Bring medical electrical equipment through an FDA regulatory pathway (Design Control) and compliance with internal Quality Management System (QMS).
- Failure mode, Safety, User and Hazard analysis creation of new and legacy devices, as well as, management of device life cycle and risk management activities in a regulated environment.
- Assist Engineering, Manufacturing and Service departments in reliability and risk analysis investigations and solutions.
- Manage tracing and provide input to requirements and specification for regulated products/applications, including design traceability and verification and validation plans.
- Develop and document integration testing, verification and validation protocols, test case execution, and test reports for both hardware and software applications.
- Support international regulations/guidance such as ISO13485:2003 and compliance.
- Resolve quality issues at incoming inspection and on the production line; provide project team leadership and conduct investigations relating to all quality issues; initiate corrective action and preventive actions (CAPA) and monitor follow-up with assigned tasks.
- Conduct internal and external quality audits according US FDA QSR regulation and ISO13485 guidance and provide insight and for subsequent corrective and preventive actions (CAPAs).
- Design and implement companywide Master Validation Plan and procedures including validations on facility, system, methods, calibrations for all instruments, equipment, as well as preventive maintenance.
Required Qualifications :
- BS Engineering or Science required.
- Minimum of 5 years experience working in FDA regulated medical device industry.
- Experience required in writing and executing verification and validations, risk management and requirement traceability for medical device industry.
- Working knowledge of FDA Quality Systems Regulations (21CFR820) and International Quality System Standards (ISO 13485).
- Experience with FMEA, Validation, Qualification and CAPA.
- Knowledge of Microsoft Word, Excel, and Outlook, MPS/MRP Systems - Master Product Scheduling and Material Requirements Planning is desirable.
Contact: Bill Zukowsky